Recall Z-0697-2014 ยท FPA Set, Administration, Intravascular
ICU Medical, Inc.
8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
| Date | Jan 9, 2014 (initiated Dec 24, 2013) |
| Status | Terminated |
| Reason | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Root cause | Equipment maintenance |
| Action | icumedical sent an Urgent Medical Device Recall letter dated December 24, 2013, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to return completed verification forms. Customers with questions were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30AM and 4:00PM Pacific Time: (866) 829-9025 and select option 8, or email: customerservice@icumed.com. ICU Medical reported an update on January 6, 2014, an expansion of the recall to additional lots. Updated recall |
| Quantity | 500 units |
| Distribution | Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970855 | CLAVE CONNECTOR Icu Medical, Inc., Jun 24, 1997 |